BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23GA ILLUMINATED DIRECTIONAL LASER PROBE

    MDR report key: 9856248 · Received March 19, 2020

    Report

    Report Number
    0001932402-2020-00002
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 26, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQB
    PMA / PMN Number
    K954306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE ACTION WILL BE PURSUED THROUGH WORKING WITH THE CUSTOMER TO PREVENT ADDITIONAL OCCURRENCES. CORRECTED DATA: SECTION D1 BRAND NAME - 23GA ILLUMINATED DIRECTIONAL LASER PROBE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA - COMMON DEVICE NAME: PHOTOCOAGULATOR AND ACCESSORIES AND PMA/510(K) #K954306 THE USER FACILITY REPORTED THE PATIENT WAS EXPERIENCING POST-OP PAIN. THE EVALUATION IS COMPLETED. THE SAMPLE WAS RETURNED WITH A PROTECTIVE CLAMSHELL. THE NEEDLE ON THE UNIT WAS BENT ALMOST 30°DOWN FROM THE HORIZONTAL PLANE. THE LIGHT PATH WAS STILL INTACT. EXAMINATION OF THE PROBE INDICATED THAT IT HAD BEEN USED GIVEN THE PRESENCE OF SOME SURGICAL DEBRIS. BOTH THE LASER FIBER AND THE ILLUMINATION FIBER LOOKED GOOD. THE UNIT WAS GIVEN TO QC FOR TESTING. QC TESTED THE PRODUCT AND FOUND THE LASER OUTPUT TO BE WITHIN SPECIFICATIONS AND THE IMAGE TO BE GOOD, USING AN IRIDEX LASER. THE ILLUMINATION OUTPUT WAS ALSO WITHIN SPECIFICATIONS AND THE IMAGE TO GOOD AS WELL, USING A PHOTON LIGHT SOURCE. THE UNIT WAS THEN TESTED ON THE R&D STELLARIS MACHINE. THE LASER WAS SET AT 500MW AND 1 SECOND, AND A READING OF 0.436 JOULES WAS OBTAINED, WHICH WAS ABOVE THE MINIMUM 0.400 JOULES REQUIRED. THE LASER PROBE PERFORMED WITHIN OPERATING SPECIFICATIONS. DEVIATION HISTORY REVIEW CONFIRMED NO DEVIATIONS WERE IN EFFECT DURING THE MANUFACTURE OF LOT M0022530. THIS INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA FROM H6 PATIENT CODES.

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE LASER DOESN''T WORK PROPERLY. IT WAS FIRING, BUT DOESN''T TREAT. THE DOCTOR REQUESTED THAT THE INTENSITY BE INCREASED GRADUALLY. STARTING FROM 250MW, SLOWLY BEGAN TO INCREASE THE INTENSITY AND STOPPED AT 1000MW, BECAUSE IT WAS CAUSING PAIN TO THE PATIENT. THE PATIENT WAS ADDITIONALLY ANESTHETIZED DUE TO THE LASER INTENSITY CAUSING SEVERE PAIN. THE OPERATION WAS STOPPED, DUE TO THE PAIN. THE LASER WAS CHANGED AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317866 23GA ILLUMINATED DIRECTIONAL LASER PROBE PHOTOCOAGULATOR AND ACCESSORIES HQB BAUSCH + LOMB 55.48.23P M0022530

    Patients

    Seq Age Sex Outcome Treatment
    1